What did the FDA approve, and when?
Daily tadalafil at 5 mg for the signs and symptoms of BPH, and for men with both BPH and ED. Drugs@FDA records both new indications for Cialis on October 6, 2011, eight years after its first approval for erectile dysfunction. The current Cialis label also covers starting it alongside finasteride, a prostate-shrinking medicine, for up to 26 weeks.
BPH symptoms are the familiar ones. The NIDDK lists trouble starting a stream, a weak or interrupted stream, dribbling, getting up at night to urinate, urgency, frequency and pain when urinating. It describes PDE5 inhibitors as relaxing the muscles around the bladder, bladder neck and prostate.
How much does it help?
Enough to notice for many men, though it is not a complete fix. Trials scored symptoms on the International Prostate Symptom Score (IPSS), which runs from 0 to 35, with higher scores meaning worse symptoms.
| Trial (from the label) | Starting score | Change on placebo | Change on tadalafil 5 mg |
|---|---|---|---|
| BPH study J, 12 weeks | About 17 | Down 2.2 | Down 4.8 |
| BPH study K, 12 weeks | About 17 | Down 3.6 | Down 5.6 |
| ED and BPH study, 12 weeks | About 18 | Down 3.8 | Down 6.1 |
Urine flow rate rose slightly in both groups, but the difference between tadalafil and placebo was not significant. So the medicine eases how symptoms feel day to day more than it changes the measured stream.
When can one pill handle both problems?
When you have both, and nothing in your history rules tadalafil out. In the trial of men with ED and BPH, 5 mg daily improved both the urinary symptom score and erectile function compared with placebo. Because the daily dose keeps a steady level, you do not need to time it around sex.
That makes daily tadalafil a tidy option for men in their fifties and sixties who are juggling both complaints. Our page on daily versus as-needed tadalafil compares the two schedules, and is daily Cialis safe covers long-term use.
When is daily Cialis the wrong choice?
In a few clear situations:
- You take nitrates of any kind, including poppers. Tadalafil is ruled out.
- You already take an alpha-blocker such as tamsulosin for BPH. The label says tadalafil is not recommended in combination with alpha-blockers for BPH, because the combination has not been adequately studied and lowers blood pressure.
- Your kidney function is very low. Daily use is not recommended when creatinine clearance is below 30 mL/min or on dialysis.
- Something else could be causing the symptoms. The label asks clinicians to consider other urinary conditions first and notes that prostate cancer and BPH can coexist. The NIDDK lists bladder problems, infections, prostatitis and prostate cancer among the look-alikes.
Get care right away if you cannot urinate at all, have painful, urgent urination with fever and chills, see blood in your urine, or have severe pain in your lower belly. The NIDDK flags these as signs that need prompt attention, and they are not a reason to start a new pill.
Does testosterone therapy make urinary symptoms worse?
In the largest trial so far, it did not. The TRAVERSE prostate safety study followed more than 5,000 men with low testosterone for about two years and found no difference between testosterone and placebo in urinary symptom scores, urinary retention or new BPH treatment. Men with severe symptoms or a PSA above 3.0 ng/mL were excluded, so it does not answer the question for everyone. Our page on BPH and testosterone has more.
How Ultimate Male evaluates urinary symptoms and ED together
At our San Gabriel and Downey clinics, your provider asks about both problems, reviews your medicines for alpha-blockers and nitrates, and checks PSA and kidney function before suggesting a daily pill. Our PSA blood test page explains why that number matters first.
If daily tadalafil fits, you get the dose your provider recommends and a follow-up to see how both complaints respond. To ask whether one daily pill could cover both problems for you, call 626-319-5261 for a free 10-minute call or browse our ED medication options.

